CTRI/2021/02/031421已完成不适用
A Double-Blind, Balanced, Randomized, Single dose, Parallel arm, Placebo controlled study to determine the Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg Manufactured by Inventia Healthcare Ltd in Healthy, Adult, Human Subjects Under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To evaluate the Pharmacokinetics of Vitamin C Sustained Release Tablets 500 mg Manufactured by Inventia Healthcare Ltd in healthy, adult human subjects under fasting conditions.
研究概览
简要总结
Ascorbic acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a slight acidic taste. It is an anti-scorbutic product.This study is being conduct to determine the Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg Manufactured by Inventia Healthcare Ltd in Healthy, Adult, Human Subjects Under Fasting Conditions.
To evaluate the Pharmacokinetics of Vitamin C Sustained Release Tablets 500 mg Manufactured by Inventia Healthcare Ltd in healthy, adult human subjects under fasting conditions.
Pharmacokinetic & Statistical Parameters
Employing the estimated concentration vs. time profiles of Vitamin C (Only Ascorbic acid) using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA, the following pharmacokinetic parameters will be calculated:
Primary parameters are Cmax, AUC0-t & AUC0-Â¥.
Secondary parameters are tmax, Kel, t½.
Statistical analysis for Vitamin C (Only Ascorbic acid)will be done using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers meeting all of the following criteria will be considered for enrollment in the study: •Subjects who agree to abstain from all vitamin C rich food / fruits etc.
- •at least 15 days before the study.
- •â€¢Normal, healthy, adult, human subjects of age between 18to 45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2 (according to the formula of BMI is equal to weight (kg) / [height (m)]2).
- •â€¢Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.
- •â€¢Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
- •â€¢Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- •â€¢Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
- •â€¢Non-smokers or ex-smokers.
- •Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •â€¢Willing to comply to all requirements of this study protocol as well as instructed by the study personnel.
- •â€¢Generally healthy as documented by gynecological examination and breast examination (for female subjects).
- •â€¢Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.
- •â€¢Female subjects of childbearing potential; •Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam and/or •Surgically sterile (bilateral tubal ligation).
排除标准
- •Volunteers with history or significant presence of the following will be excluded from participation/enrollment in the study: •Evidence of allergy or known hypersensitivity to Vitamin C or its inactive ingredients.
- •â€¢Subjects having plasma levels of vitamin C ≤ 11 µmol/L during screening •Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus and pre-existing gallbladder disease.
- •â€¢ Any major illness in the last three months or any significant ongoing chronic medical illness.
- •â€¢ Renal or liver impairment.
- •â€¢Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, or any other body system.
- •â€¢History or presence of alcohol addiction or abuse.
- •â€¢Consumption of caffeine and /or xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study.
- •â€¢Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study.
- •â€¢Subjects who have taken any prescription medications or any vitamin C supplements within 14 days prior to study check-in and throughout the study and any over the counter medicinal products, herbal medications within 15 days prior to study check-in and throughout the study.
- •â€¢Subjects who have taken an unusual diet, for whatever reason (e.g. low salt or vitamin C ) for 48.00 hours prior to dosing and throughout the study.
- •â€¢Subject who had participated in any other study within the 90 days of check-in.
- •â€¢History of difficulty in swallowing.
- •â€¢History of difficulty in accessibility of veins.
- •â€¢Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of this study period.
- •â€¢Any blood donation / excess blood loss within 90 days of check-in.
- •â€¢Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
- •â€¢Use of hormone replacement therapy for a Period of 06 months prior to dosing.
- •â€¢Female subjects demonstrating a positive pregnancy screen.
- •â€¢Female subjects who are currently lactating.
结局指标
主要结局
To evaluate the Pharmacokinetics of Vitamin C Sustained Release Tablets 500 mg Manufactured by Inventia Healthcare Ltd in healthy, adult human subjects under fasting conditions.
时间窗: 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours
次要结局
- To monitor the safety and tolerability of a single dose administered in Healthy, Adult, Human Subjects under Fasting conditions.(00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours)
研究者
研究点 (1)
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